Senior Bioassay Method Transfer Lead

Merck; Salamanca; Presencial; EUR 90.000 - 110.000; Jornada completa

Descripción de la vacante

Merck is seeking a Senior Method Transfer Specialist (Bioassays) based in Salamanca to coordinate and execute analytical transfers for large-molecule products. You will act as a subject-matter expert to drive early-phase development, transfer readiness and right-first-time implementations across R&D and QC laboratories.

You will lead cross-functional teams, review documentation, and ensure alignment with regulatory expectations (GxP).

Formación

• Bachelor's or Master's degree in Biological Sciences, Pharmaceutical Sciences, Analytical Sciences, or related.
• Multi-year experience in pharma/biotech analytics of large molecules (bioassays).
• Experience in analytical method development, validation, transfer in GxP environments.
• Strong knowledge of GMP/GLP expectations and transfer documentation.

Responsabilidades

• Coordinate and execute large molecule analytical method transfers across EU/APAC.
• Lead transfer plans with timelines, milestones, and documentation.
• Review protocols and reports; ensure readiness criteria and acceptance criteria.
• Provide troubleshooting and data-driven analytical guidance across development, transfer and implementation.
• Coordinate cross-site transfer workstreams; drive investigations and remediation actions.
• Build relationships with R&D, QC, QA, RA and Data Science teams.

Conocimientos

Analytical depth

Project management

Negotiation & influence

Communication skills

Cross-functional collaboration

GMP/GLP knowledge

R&D-QC interface

Bilingual: Spanish & English

Educación

Bachelor's or Master's in Biological/Pharmaceutical/Analytical Sciences

Herramientas

Minitab

Descripción del empleo

Merck is seeking a Senior Method Transfer Specialist (Bioassays) based in Salamanca to coordinate and execute analytical transfers for large-molecule products. You will act as a subject-matter expert to drive early-phase development, transfer readiness and right-first-time implementations across R&D and QC laboratories.

You will lead cross-functional teams, review documentation, and ensure alignment with regulatory expectations (GxP).